In 2004, the BfArM issued a recommendation on automatically height-adjustable therapy tables.

We have recommended to generally design automatically height-adjustable therapy tables in a way, that inadvertently operation of the control is prevented or that inadvertently operation will not result in endangerment. Products, which do not meet this demand, should be refitted.

As a possible example of implementation, the recommendation mentioned amongst others a locking funktion. In view of the possible available solutions at that time and the retrofitting in the field, this was also chosen primarly as a measure for therapy tables newly placed on the market.

Our recommendation of the year 2004 was partially misinterpreted in a way that BfArM explicitly demanded a locking function and that this had to be regarded as "state of the art".

Thus, BfArM points out that a recommendation of the BfArM - here moreover more than 10 years old - does not release the manufacturer from the obligation to continuously develop his product on his own responsibility via the risk management system in accordance with new market findings and the current technical possibilities regarding the concept of integrated safety.

Technical developments of recent years meanwhile have made solutions available that are even more deeply anchored in the design of the recliners and take the concept of integrated security more into account than a locking function, which still requires the user's intervention and does not correspond to the highest level of the principle of integrated security.

Our current recommendation on the subject is therefore also design focused and is as follows:

Energy-based adjustable therapy tables must be designed in such a way that persons cannot be trapped in the adjustment mechanism with serious consequences.

The solutions chosen must be based on the principle of integrated safety and must therefore be anchored as centrally as possible in the design of the product, i.e. at the level of the lifting and drive system.
Manufacturers must adhere to this.

Proceedings with regard to the installed base have to be discussed with the local competent authorities.
According to German medical device law, the local competent authorities are responsible for the enforcement and monitoring of the measures.

The control of the implementation of the measures as well as the monitoring of operators and facilities are also carried out by the local competent authorities in accordance with German medical device law. Questions regarding the implementation of measures and their application must therefore be clarified with the relevant local supervisory authority.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-5384 (active medical devices and in vitro diagnostics)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de